BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED PRIMARY PLUM SET

    MDR report key: 20359264 · Received October 3, 2024

    Report

    Report Number
    9615050-2024-00726
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    July 10, 2024
    Report Date
    October 7, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005315
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION D4.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS UNSPECIFIED. WITHOUT A LOT NUMBER THE MANUFACTURING AND EXPIRATION DATE. 510K - K141789 - WAS SELECTED AS REPRESENTATIVE OF THE PRODUCT AS A PLACE HOLDER. INVESTIGATION SUMMARY: RECEIVED THREE (3) USED CH-14, TWO (2) USED LIST #UNKNOWN PRIMARY PLUM SET AND OTHER MATING DEVICES FOR INSPECTION. EACH OF THE FILTERS AT THE DRIP CHAMBER WERE WETTED OUT WITH PRIOR INFUSATE. EACH SET WAS LEAK TESTED PER PRODUCT SPECIFICATIONS. THERE WAS LEAKAGE FROM THE DRIP CHAMBER FILTER FROM VARIOUS LOCATIONS. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE PROBABLE CAUSE OF LEAKAGE IS DUE TO A TEMPORARY OR COMPLETE LOSS OF HYDROPHOBIC PROPERTIES OF THE FILTER VENT MATERIAL DUE TO AN INFUSATE INTERACTION DURING USE. LOT HISTORY REVIEW WAS UNABLE TO BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE COMPLAINT INVOLVED TWO UNSPECIFIED PLUM SETS EXPERIENCING NO FLOW. THE CUSTOMER RETURNED A MATING DEVICE SAMPLE WHICH WAS A PRIMARY PLUM SETS. DURING INSPECTION, THE PLUM SETS WERE FOUND WITH THE REPORTED DEFECT ON THE TWO (2) USED LIST #UNKNOWN PRIMARY PLUM SETS. THEREFORE, A COMPLAINT IS BEING REGISTERED TO CAPTURE THE AIR VENT NO FUNCTION OF THE MATING DEVICE THAT WAS RETURNED WITH THE CHEMOCLAVE® VENTED BAG. THE ISSUE INITIALLY REPORTED UNDER THE CHEMOCLAVE® VENTED BAG. THE REPORTER STATED, ¿THE AIR VENT WAS NO FUNCTION. WHEN USED CH14 TO THE PP BOTTLE OF CHEMO MEDICINE, IT CAN¿T INFUSE." THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870068 UNSPECIFIED PRIMARY PLUM SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. UNKNOWN 10887787005315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown